Yôga and Breathing Techniques Training in Patients With Heart Failure and Preserved Ejection Fraction

Yôga and Breathing Techniques Training in Patients With Heart Failure and Preserved Ejection Fraction: Study Protocol for a Randomized Clinical Trial

Current therapies for heart failure (HF) bring together strategies to improve quality of life and exercise tolerance, as well as to reduce morbidity and mortality. Some HF patients present changes in the musculoskeletal system and inspiratory muscle weakness, which may be restored by inspiratory muscle training, thus increasing respiratory muscle strength and endurance, maximum oxygen consumption (VO2), functional capacity, respiratory responses to exercise, and quality of life. Yoga therapies have been shown to improve quality of life, inflammatory markers, and VO2 peak in HF patients, mostly with reduced ejection fraction (HFrEF). However, the effect of different yoga breathing techniques in patients with HF with preserved ejection fraction (HFpEF) has yet to be assessed.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Heart Failure; Heart Failure, Diastolic
• Intervention / Treatment: Other: Yôga; Other: Breathing technique; Other: Control group

Detailed Description

Yôga techniques without breathing control have shown to improve oxygen consumption in patients with HF, mostly HFrEF. However, almost half of HF patients present with HFpEF, and less studies have been performed in those patients. It has been recently demonstrated that HFpEF induces significant molecular, mitochondrial, histological, and functional alterations in the diaphragm and soleus, which were attenuated by exercise training . In cardiac disease and aging, several authors have shown a significant reduction in heart rate variability (HRV) in the frequency ranges associated with breathing, by using spectral analysis of heart rate (HR) and respiration.Therefore, the present randomized clinical trial (RCT) will be conducted in order to test the hypothesis that an program of yôga and specific breathing techniques with different ventilatory rhythms could be associated with improvement in inspiratory muscle responses, functional capacity, oxygen uptake efficiency slope (OUES), circulatory power, oscillatory ventilation, kinetics of oxygen consumption in the recovery period, distinct features of the autonomic nervous system, natriuretic peptides, echocardiographic measurements, and quality of life (QoL) in patients with HFpEF, with and without inspiratory muscle weakness (IMW).Therefore, the present randomized clinical trial (RCT) will be conducted in order to test the hypothesis that an 8-week program of yôga and specific breathing techniques with different ventilatory rhythms could be associated with improvement in inspiratory muscle responses, functional capacity, oxygen uptake efficiency slope (OUES), circulatory power, oscillatory ventilation, kinetics of oxygen consumption in the recovery period, distinct features of the autonomic nervous system, natriuretic peptides, echocardiographic measurements, and quality of life in patients with HFpEF, with and without IMW.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Canoas, Rio Grande Do Sul, Brazil, 92425900
      • Hospital ULBRA - Mãe de Deus
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
      • Hospital de Clínicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients with a diagnosis of HFpEF, functional capacity class II and III, who are being treated at a specialized HF clinic will be eligible. HF diagnosis will be established by clinical history (signs and symptoms), echocardiographic findings (left ventricular ejection fraction ≥ 50%) and medical records confirming management for HF.

Exclusion Criteria:

• Pulmonary disease (forced vital capacity<80% of predicted and/or forced expiratory volume in 1 s <70% of predicted, significant mitral or aortic valve diseases, history of exercise-induced asthma, and active smoking or alcoholic.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Yôga; Active protocol with yôga body movements performed along with respiratory vigorous, without contentions. Two sessions per week, with 45 minutes duration.	Other: Yôga; Intervention observing respiratory frequency (RF) of 15- 20 respiratory cycles per minute (rcpm). A standardized 7-minute final relaxation .
Experimental: Intervention breathing technique; Passive protocol, seated patient, no significant body movements. Breathing technique, with alternate nostril breathing combined to inspiratory and expiratory retentions.Two sessions per week, with 45 minutes duration	Other: Breathing technique; Intervention uses diaphragmatic breathing, observing slow respiratory frequency, between 5-8 rcpm. A standardized 7-minute final relaxation.
Experimental: Control group; Control group (standard pharmacological treatment). Patients will be oriented to keep their pharmacological routine and daily activities, with no structured exercises. They will have to return to the hospital for post-testing after 8 weeks from randomization.	Other: Control group; Patients will be oriented to keep their pharmacological routine and daily activities, with no structured exercises. They will have to return to the hospital for post-testing after 8 weeks from randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal inspiratory pressure (PImax)	Inspiratory muscle strength by measuring maximal inspiratory pressure (PImax)	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen uptake (peak VO2)	Peak VO2 will be considered the highest value of VO2 calculated in a 20-second-period during cardiopulmonary exercise testing (CPET)	Baseline and 8 weeks
Vagal activity: heart rate variability- HRV	Twenty-four-hour ECG recordings will be obtained with a light digital recorder for to available of heart rate variability (HRV).	Baseline and 8 weeks
Functional capacity through the 6-minute walk test (6MWD)	The maximum distance walked in 6 minutes of walking (6MWD).The distance traveled in the time of 6 minutes will be considered according to the predicted for gender and age of the patient.	Baseline and 8 weeks
Quality of life Minnesota scores	Quality of life Minnesota scores as a specific inventory for patients with Heart Failure.	Baseline and 8 weeks
N-terminal pro-brain natriuretic (NT-proBNP)	NT-proBNP test: N-terminal precursor of natriuretic peptide type B (Brain), clinical specimen by serum, sandwich-type electrochemiluminescence analysis method (COBAS E601-ROCHE).	Baseline and 8 weeks
Echocardiographic - Ejection Fraction	Teichholz method: ejection fraction - study Inclusion criteria: EF≥ 50% . Establish a diagnostic measure of HF by confirming preserved ejection fraction and compare this measure at the end of the study.	Baseline and 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other pulmonary functions - Inspiratory muscle force	Additionally, for the determination of inspiratory muscle force, an incremental test will be used in which patients will breathe continuously through a mouthpiece connected to a measure device. The patients will use an initial load of 50% of PImax, and increments of 10% of PImax will be added every 3 min until the patient is unable to continue breathing.	Baseline and 8 weeks
Oher pulmonary functions - Inspiratory muscle endurance	Additionally, for the determination of inspiratory muscle endurance, an incremental test will be used in which patients will breathe continuously through a mouthpiece connected to a measure device. The protocol, subjects will breathe against a constant inspiratory submaximal load equivalent to 80% of the greatest inspiratory pressure and the time elapsed to task failure will be defined as the inspiratory endurance time.	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Andréia Biolo, MD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

General Publications

• Lopes CP, Danzmann LC, Moraes RS, Vieira PJC, Meurer FF, Soares DS, Chiappa G, Guimaraes LSP, Leitao SAT, Ribeiro JP, Biolo A. Yoga and breathing technique training in patients with heart failure and preserved ejection fraction: study protocol for a randomized clinical trial. Trials. 2018 Jul 28;19(1):405. doi: 10.1186/s13063-018-2802-5.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Yôga; Breathing Techniques; Heart Failure and Preserved Ejection Fraction
• Additional Relevant MeSH Terms: Heart Diseases; Heart Failure; Cardiovascular Diseases; Heart Failure, Diastolic
• Other Study ID Numbers: 110069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED